In April 2014, the U.S. Food and Drug Administration (FDA) warned doctors that a laparoscopic power morcellator, used to remove common benign uterine growths known as fibroids and in minimally invasive hysterectomies, can spread undetected cancer. In August Johnson & Johnson pulled the device from the market; some hospitals stopped using it and some insurers stopped covering its use. However, there are many doctors nationwide ignoring the FDA’s warning as they continue to use the gynecological tool.
The FDA regulates pharmaceuticals and medical devices but doesn’t oversee the practice of medicine, where doctors have wide latitude. In April the agency estimated that 1 in 350 women undergoing surgery for fibroids have an undetected dangerous cancer that the tool can spread—far higher than the risk was generally believed to be—and discouraged its use. The move sharply divided the field while prodding many gynecologists to stop using the tool. Some are exploring other minimally invasive options.
The number of gynecologists still employing morcellators is difficult to estimate. The American College of Obstetricians and Gynecologists, the field’s main medical society, isn’t tracking it. But interviews with many doctors show that a segment of the field has dug in to defend its use, with more informed consent and some adaptations.
Their decision reflects their skepticism that the FDA acted too quickly and spooked women who could benefit from a surgery that the FDA estimated in April was being performed at least 50,000 times a year.
There were doctors who declared they believe the risks of unknown cancer have been overblown and the government shouldn’t interfere with patient treatment. “It is none of their business,” said Jeffrey Thurston, 58, a Dallas gynecologist who has practiced for three decades and said he performs 80% of his hysterectomies with a morcellator.
However, since the FDA’s warning gynecologists are informing morcellator risks to their patients which they acknowledge was seldom done before. But the experience and opinions of individual doctors can color how they relay this information to their patients and a patient’s trust factor in their doctor might determine her decision and next steps. Doctors are also having the patients sign a consent form before undergoing the procedure and being more selective with their patients in general.
Patients should be made aware of any potential risks when facing surgery, even a minimally invasive one. Doctors’ resistance to the FDA proves how difficult it is for their practices to be regulated. This is a good reminder to not only ask your physician questions, but also do your own research when it comes to your health and well-being.